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Dementia of the Alzheimer's TypePhase 3NCT00322153

A Study of the Safety and Efficacy of Memantine in Moderate to Severe Alzheimer's Disease

A Phase 3 study testing memantine ER in people with Dementia of the Alzheimer's Type, run by Forest Laboratories at 83 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The objective of this study is to evaluate the safety, tolerability, and efficacy of memantine compared to placebo in outpatients diagnosed with moderate-to-severe dementia of the Alzheimer's type on a concurrent acetylcholinesterase inhibitor (AChEI). Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Dementia of the Alzheimer's Type
What is being tested?
memantine ER
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
677 participants
Where
83 sitesin 4 countries
Study dates
Jun 2005to Jan 2008
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Ambulatory patients aged >/= 50 years
  • Diagnostic evidence of probable Alzheimer's disease consistent with criteria from the National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) and the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR)
  • Confirmatory magnetic resonance imaging (MRI) or computed tomographic (CT) scan within the prior 12 months.
  • Mini-Mental State Examination (MMSE) scores >/= 3 and </= 14 at Screening (Visit 1) and Baseline (Visit 2)
  • Ongoing daily acetylcholinesterase inhibitor (AChEI) therapy at a stable dose for at least 3 months prior to Screening (Visit 1). It is preferred that patients continue to receive the same AChEI therapy for the duration of the study.

Who cannot join

  • Patients with a modified Hachinski Ischemia Score greater than 4 at Screening.
  • Patients who have taken memantine within one month of Screening (Visit 1)
  • Patients who have a known hypersensitivity to memantine, neramexane, rimantadine, or amantadine.
  • Patients whose AChEI therapy is likely to be interrupted or discontinued during the course of the study.
  • Patients who are receiving therapy with more than one AChEI.
  • Patients with computed tomography (CT) or magnetic resonance imaging (MRI) evidence of hydrocephalus, stroke, a space-occupying lesion, cerebral infection, or any clinically significant central nervous system disease other than Alzheimer's disease.
Show all 11Show fewer
  • Patients with a DSM-IV Axis I disorder other than Alzheimer's disease, including amnestic disorders, schizophrenia or schizoaffective disorder, bipolar disorder, current major depressive episode, psychosis, panic, or post-traumatic stress disorder.
  • Patients who, in the clinician's judgement, are likely to be placed in a nursing home within the next 6 months.
  • Patients who had evidence of other neurological disorders that included, but were not limited to, stroke, Parkinson's disease, seizure disorder, or head injury with loss of consciousness within the prior 5 years
  • Patients who had dementia that was complicated by other organic disease
  • Patients who had dementia complicated by the presence of predominant delusions

Trial locations and contacts

83 sites in 4 countries.

83 sites in 4 countries

United States38 sites

  • Forest Investigative Site 048

    Albany, New York, 12205

  • Forest Investigative Site 041

    Austin, Texas, 78757

  • Forest Investigative Site 021

    Boca Raton, Florida, 33486

  • Forest Investigative Site 052

    Boynton Beach, Florida, 33426

  • Forest Investigative Site 006

    Buffalo, New York, 14215

  • Forest Investigative Site 027

    Centerville, Ohio, 45459

  • Forest Investigative Site 062

    Costa Mesa, California, 92626

  • Forest Investigative Site 070

    Delray Beach, Florida, 33445

  • Forest Investigative Site 002

    Denver, Colorado, 80262

  • Forest Investigative Site 067

    East Providence, Rhode Island, 02914

  • Forest Investigative Site 065

    Fort Myers, Florida, 33912

  • Forest Investigative Site 050

    Fresno, California, 93720

  • Forest Investigative Site 032

    Greensburg, Pennsylvania, 15601

  • Forest Investigative Site 043

    Hallandale, Florida, 33009

  • Forest Investigative Site 044

    Hallandale, Florida, 33009

  • Forest Investigative Site 018

    Jenkintown, Pennsylvania, 19046

  • Forest Investigative Site 069

    Joliet, Illinois, 60435

  • Forest Investigative Site 045

    Kalamazoo, Michigan, 49048

  • Forest Investigative Site 064

    Long Branch, New Jersey, 07742

  • Forest Investigative Site 001

    Miami, Florida, 33137

  • Forest Investigative Site 011

    Morristown, New Jersey, 07960

  • Forest Investigative Site 003

    New Brunswick, New Jersey, 08903

  • Forest Investigative Site 034

    North Miami, Florida, 33161

  • Forest Investigative Site 068

    Orlando, Florida, 32806

  • Forest Investigative Site 038

    Palm Beach Gardens, Florida, 33410

  • Forest Investigative Site 010

    Phoenix, Arizona, 85004

  • Forest Investigative Site 020

    Portland, Oregon, 97210

  • Forest Investigative Site 013

    Richmond, Virginia, 23229

  • Forest Investigative Site 014

    Saint Loius, Missouri, 63104

  • Forest Investigative Site 017

    San Antonio, Texas, 78229

  • Forest Investigative Site 024

    San Francisco, California, 94118

  • Forest Investigative Site 071

    Santa Ana, California, 92705

  • Forest Investigative Site 009

    Snellville, Georgia, 30078

  • Forest Investigative Site 008

    St. Petersburg, Florida, 33709

  • Forest Investigative Site 026

    Tacoma, Washington, 98405

  • Forest Investigative Site 028

    Tampa, Florida, 33617

  • Forest Investigative Site 012

    Toledo, Ohio, 43623

  • Forest Investigative Site 004

    White Plains, New York, 10605

Other trials in United States

Argentina23 sites

  • Forest Investigative Site 103

    Banfield, Buenos Aires, B1828CKR

  • Forest Investigative Site 102

    Buenos Aires, Buenos Aires, 1419HDN

  • Forest Investigative Site 118

    Buenos Aires, Buenos Aires, C1062ABF

  • Forest Investigative Site 109

    Buenos Aires, Buenos Aires, C1117ABE

  • Forest Investigative Site 104

    Buenos Aires, Buenos Aires, C1122AAJ

  • Forest Investigative Site 108

    Buenos Aires, Buenos Aires, C1126AAB

  • Forest Investigative Site 114

    Buenos Aires, Buenos Aires, C1181ACH

  • Forest Investigative Site 106

    Buenos Aires, Buenos Aires, C1209AAB

  • Forest Investigative Site 119

    Buenos Aires, Buenos Aires, C1405CNF

  • Forest Investigative Site 122

    Buenos Aires, Buenos Aires, C1413FWO

  • Forest Investigative Site 107

    Buenos Aires, Buenos Aires, C1419AHN

  • Forest Investigative Site 111

    Buenos Aires, Buenos Aires, C1425AGP

  • Forest Investigative Site 121

    Buenos Aires, Buenos Aires, C1425BPK

  • Forest Investigative Site 115

    Buenos Aires, Buenos Aires, C1428AQK

  • Forest Investigative Site 116

    Buenos Aires, Buenos Aires, C1428AQK

  • Forest Investigative Site 112

    Córdoba, Córdoba Province, X5000ALB

  • Forest Investigative Site 124

    Córdoba, Córdoba Province, X5004AOA

  • Forest Investigative Site 105

    La Plata, Buenos Aires, B1900AVG

  • Forest Investigative Site 123

    Lanus, Buenos Aires, C1824IBR

  • Forest Investigative Site 110

    Mendoza, Mendoza Province, M5500HYF

  • Forest Investigative Site 125

    Mendoza, Mendoza Province, M5504FMI

  • Forest Investigative Site 113

    Rosario, Santa Fe Province, S2000DSV

  • Forest Investigative Site 120

    Santa Fe, Santa Fe Province, S3000FWO

Other trials in Argentina

Chile11 sites

  • Forest Investigative Site 302

    Antofagasta, Antofagasta

  • Forest Investigative Site 308

    Coquimbo, Elqui

  • Forest Investigative Site 301

    Las Condes, Santiago Metropolitan

  • Forest Investigative Site 309

    Las Condes, Santiago Metropolitan

  • Forest Investigative Site 303

    Providencia, Santiago Metropolitan

  • Forest Investigative Site 310

    Providencia, Santiago Metropolitan

  • Forest Investigative Site 313

    Recoleta, Santiago Metropolitan

  • Forest Investigative Site 305

    San Ramón, Santiago Metropolitan

  • Forest Investigative Site 304

    Santiago, Santiago Metropolitan

  • Forest Investigative Site 312

    Santiago, Santiago Metropolitan

  • Forest Investigative Site 306

    Valdivia, Valdivia

Other trials in Chile

Mexico11 sites

  • Forest Investigative Site 206

    Aguascalientes, Aguascalientes, 20230

  • Forest Investigative Site 213

    Culiacán, Sinaloa, 80400

  • Forest Investigative Site 205

    Guadalajara, Jalisco, 44610

  • Forest Investigative Site 211

    León, Guanajuato, 37000

  • Forest Investigative Site 202

    Mexico City, Federal District, 14000

  • Forest Investigative Site 207

    Mexico City, Federal District, 14050

  • Forest Investigative Site 208

    Monterrey, Nuevo León, 44610

  • Forest Investigative Site 204

    Monterrey, Nuevo León, 64710

  • Forest Investigative Site 212

    Saltillo, Coahuila, 25000

  • Forest Investigative Site 210

    San Luis Potosí City, San Luis Potosí, 78090

  • Forest Investigative Site 203

    Zapopan, Jalisco, 45200

Other trials in Mexico

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled Evaluation of the Safety and Efficacy of Memantine in Patients With Moderate-to-Severe Dementia of the Alzheimer's Type

The objective of this study is to evaluate the safety, tolerability, and efficacy of memantine compared to placebo in outpatients diagnosed with moderate-to-severe dementia of the Alzheimer's type on a concurrent acetylcholinesterase inhibitor (AChEI).

Read the detailed description

Memantine is a therapeutic agent that represents a unique class of Alzheimer's disease (AD) treatment options. A once daily (QD) dosing regimen in an AD population would simplify administration for the caregiver. The purpose of this study is to evaluate the safety and efficacy of modified release memantine taken once daily in outpatients with moderate-to-severe AD on a concurrent AChEI.

Being tested
memantine ER, Placebo
Keywords
memantine, Alzheimer's disease, moderate to severe Alzheimer's disease
Medical subject headings
Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • memantine ERDrug

    Also called Namenda XR

    28mg(7mg capsules) once daily and oral administration for 24 weeks.

  • PlaceboDrug

    Matching placebo oral administration once daily.

Study groups in NCT00322153
Study groupRoleWhat they receive
PlaceboPlacebo comparatorOral administration, once daily.
Receives: Drug: Placebo
Memantine ERActive comparator28mg, once daily. Oral administration for 24 weeks.
Receives: Drug: memantine ER

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline in Severe Impairment Battery (SIB) at Week 24 (LOCF)

    The SIB was developed for the evaluation of cognitive function in patients with more advanced dementia, and evaluates the areas of memory, language, praxis, orientation, and attention. The SIB test items consist of simple, one-step commands presented with gestural cues that are repeated if necessary. The test contains 51 items, and the range of possible scores is 0 to 100 (with 0 being the worst result). The SIB has been shown to be a valid and reliable instrument sensitive to longitudinal change.

    Measured: Baseline to week 24

  2. Clinician's Interview-Based Impression of Change With Caregiver Input (CIBIC-plus) at Week 24 (LOCF)

    The CIBIC-Plus is a measure of an overall clinical effect and is based on a comprehensive evaluation at Baseline and later visits of four domains: general (overall clinical status), functional (including activities of daily living), cognitive, and behavioral. A skilled clinician interviews the patient, and includes information supplied by a knowledgeable caregiver. The CIBIC-Plus is a rating of the patient's global status relative to Baseline, ranging from a score of 1, indicating "marked improvement" to a score of 4, indicating "no change" to a score of 7, indicating "marked worsening."

    Measured: Week 24

Secondary outcomes (1)

  1. Change From Baseline in the 19-Item Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL19) Scale at Week 24 (LOCF)

    The ADCS-ADL19 modified inventory consists of 19 items used to measure the functional capabilities of patients with moderate to severe dementia. Each activity-of-daily-living (ADL) item comprises a series of hierarchical subquestions ranging from the highest level of independent performance to complete loss of ability to perform the ADL Inventory. The inventory is performed by interviewing a person in close contact with the patient and covers the most usual and consistent performance of the patient over the preceding 4 weeks. Response range is 0 (total disability) to 54 (total independence).

    Measured: Baseline to week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 May 2006 (estimated)
  2. Study startJun 2005
  3. Primary completionOct 2007
  4. Study completionJan 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
677 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00322153
Sponsor's protocol ID
MEM-MD-50
Status last verified
Aug 2010
First submitted
3 May 2006
Last updated
16 Sep 2010
Data monitoring committee
No

Publications

  • Grossberg GT, Alva G, Hendrix S, Ellison N, Kane MC, Edwards J. Memantine ER Maintains Patient Response in Moderate to Severe Alzheimer's Disease: Post Hoc Analyses From a Randomized, Controlled, Clinical Trial of Patients Treated With Cholinesterase Inhibitors. Alzheimer Dis Assoc Disord. 2018 Jul-Sep;32(3):173-178. doi: 10.1097/WAD.0000000000000261.

    PubMed 29771687

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing memantine ER in people with Dementia of the Alzheimer's Type, run by Forest Laboratories at 83 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 83 sites in United States, Argentina, Chile, Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Sep 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Severe Impairment Battery (SIB) at Week 24 (LOCF) (time frame: Baseline to week 24). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00322153, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2010.

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